Medicinal cannabis: the production chain that CEIS didn't plan

Ou: a cadeia que nasceu de uma sentença

Since August 4th, ANVISA (Brazilian Health Regulatory Agency) has been receiving requests for Special Authorization from companies interested in cultivating Cannabis sativa in Brazil for medicinal purposes. This date marks the operational start of a new production chain, but news reports still primarily treat the issue as another step in the regulation of cannabis.

The most interesting aspect lies elsewhere: the timeline for medicinal cannabis policy was largely defined by the Judiciary. Not by the Ministry of Health or the executive group of the Economic-Industrial Complex of Health , but by the First Section of the Superior Court of Justice .

The story originated with a biotechnology company, DNA Soluções , which intended to import hemp seeds with a THC content of up to 0.3% and ran into Ordinance 344/1998. The process ended up leading to the Incident of Assumption of Jurisdiction No. 16. In November 2024, the Superior Court of Justice (STJ) established a binding precedent allowing the planting and commercialization by legal entities for exclusively medicinal and pharmaceutical purposes and set a six-month deadline for the Federal Government and ANVISA (Brazilian Health Regulatory Agency) to regulate the activity.

This deadline was extended three times. There was an approved and binding action plan, and in April 2026, the court recognized compliance with the ruling. The process resulted in the set of resolutions published in February, RDCs 1.011 to 1.015, which came into full effect in August.

The result is a pharmaceutical supply chain that was born under strong judicial pressure . I don't necessarily consider this a problem. The judiciary ended up unlocking a discussion that had remained for years between the administrative and legislative spheres. But there is a predictable effect when a regulation is built with a judicial deadline running: there is a tendency to prioritize control and risk reduction .

This is what appears in the new rules. The Special Authorization is exclusive to legal entities, requires prior sanitary inspection, traceability integrated into the controlled products system, permanent safety requirements for the facilities, and the possibility of immediate suspension in case of irregularities.

It is also necessary to clarify what is actually being authorized. Cultivation for medicinal purposes is restricted to plants with THC levels up to 0.3% . Above this limit, cultivation is permitted only for research and under additional requirements . Products covered by RDC 1.015 must be industrially processed and contain exclusively cannabidiol or extracts with a predominance of CBD. THC above 0.2% is reserved for specific clinical situations. Dried flowers and smoking products remain prohibited.

The chain that begins now, therefore, is not a cannabis chain in the broad sense. It is primarily a hemp and cannabidiol chain .

There is also a regulatory decision with clear implications for industrial policy. The export of the plant species and seeds remains prohibited , while the update to Annex I of Ordinance 344, in May, authorized the export of active pharmaceutical ingredients and derived products manufactured in the country.

In practice, Brazil has restricted the export of raw materials and opened up space for the export of manufactured products . Anyone wishing to build an international business from cannabis grown here will have to add value before reaching the foreign market. It's an industrial policy choice embedded in a sanitary regulation .

The economic logic behind this choice deserves attention. High-purity cannabidiol isolate is already a global commodity , traded in kilograms, and the international market has gone through significant cycles of oversupply since the expansion of hemp in the United States in 2018. The Hemp Benchmarks index, one of the benchmark prices in the American sector, recorded a 25% drop in the price of CBD isolate in June compared to the previous year.

Canada is an example of this risk. After 2018, there was a strong expansion of cultivation capacity, followed by oversupply and value destruction . Colombia also bet on low-cost production geared towards export and did not achieve the initially projected expectations.

For Brazilian producers, the calculation tends to be even more difficult. Cultivating under a high level of sanitary compliance to compete with low-cost imported isolates requires a very favorable cost structure and commercial strategy. The most defensible margin will likely be in later stages of the chain: appropriate grade pharmaceutical inputs, regulated products, and formulations with higher added value.

Brazilian Regulatory Decree 1.015 also opened the door for compounded cannabidiol formulations with a minimum purity of 98%, although this area still depends on specific regulations regarding good manufacturing practices.

The market that this new chain aims to supply, on the other hand, already exists and has scale. Since 2022, the exceptional import route for individuals foreseen in RDC 660 has accumulated more than 660,000 requests . There were 110,000 in the first half of 2026 alone, according to data obtained from Anvisa by the Cannabis & Health portal.

Over 500 companies operate within this system, offering around 600 products , almost all of which are imported. KayaMind estimates this market at approximately R$1 billion this year.

In the vote that justified the revision of the old RDC 327, ANVISA itself classified the model as a regulatory distortion that required revision. The signal to the market is significant: the channel that currently concentrates a large part of the access to imported products should not remain indefinitely with the same weight.

This creates an opportunity for the national industry , but it doesn't mean that all current participants in the chain have the same chances. My expectation is that the migration will primarily favor established pharmaceutical companies , compounding networks , and some vertically integrated entrants capable of sustaining investments during the two or three years needed to go through regulatory and operational maturation.

Growers who were already operating under court orders have until August 2027 to adapt to the new regime. This period will be particularly important for separating projects with a consistent industrial thesis from those that simply gambled on opening up cultivation.

This is where the discussion ceases to be purely regulatory.

Brazil already has a National Strategy for the CEIS (Center for Strategic Information on Health) , programs focused on innovation in health, and relatively sophisticated instruments for planning supply chains considered strategic. Even so, a rapidly growing supply chain needed to enter the regulatory system through a lawsuit filed by a company that wanted to import seeds.

This can be interpreted in two ways. The episode illustrates the gap between the speed of market transformations and the ability of public policies to anticipate them . It also exposes the difficulty of addressing issues that carry a strong political and social stigma before a court decision forces the State to confront them.

Both things could be happening at the same time.

For those who follow the formation of new healthcare chains in Brazil, this is perhaps the most relevant aspect of the cannabis case. Beyond defining who can cultivate it, the new rules are beginning to establish where the economic value of this chain will lie and which companies will be able to capture it.

At the Brazilian Institute for Innovation in Health - IBIS, we monitor the structuring of new production chains in the sector and the regulatory decisions that define who can participate in them, paying attention to the implications of these milestones for industrial policy and innovation in health in Brazil.

by Marcio de Paula

Founder of the Brazilian Health Innovation Institute - IBIS, with over 25 years of experience in life sciences, he has held strategy and innovation positions in companies such as Biolab and Ferring Pharmaceuticals , founded the Brazilian Pharmaceutical Innovation Network , and is a member of health innovation boards in Brazil. He writes about the paths to radical innovation in health and how to connect science, industry, and public policy.